Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial of BioBlock COVID-19 Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04916574
Recruitment Status : Completed
First Posted : June 7, 2021
Last Update Posted : June 9, 2021
Sponsor:
Collaborator:
Tartu University Hospital
Information provided by (Responsible Party):
Icosagen Cell Factory

Brief Summary:
For an antiviral agent to act as an effective biological barrier on nasal mucosal surface, the formulation preferably has to be maintained on the site of action for several hours, and the nasal spray dispenser can be utilized for administering the solution to the upper respiratory tract. A "first-in-man" clinical study of the nasal spray containing anti-SARS-CoV-2 antibodies derived from bovine colostrum was conducted. The study on healthy volunteers was undertaken to evaluate how long the bovine antibodies would be maintained on the nasopharyngeal surface after administration of nasal spray. In addition, the study enabled to determine which of the two concentrations of antibodies should be used in the final nasal-spray formulation. The volunteers were followed up for 4h after administration of antibody spray and sampling was done at different time-points during this period. The concentration of antibodies from patient samples was measured using ELISA analysis. In addition, as this was a "first-in-man" study any adverse events following the administration of spray were also monitored.

Condition or disease Intervention/treatment Phase
SARS-COV2 Infection Covid19 Other: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum Not Applicable

Detailed Description:
To test the nasal biological availability of the BioBlock® immunoglobulin preparation, 16 healthy volunteers were recruited in the phase 0 clinical trial. The study was conducted in the premises of the Ear Clinic of Tartu University Hospital. The study protocol was approved by Research Ethics Committee of the University of Tartu on March 17, 2021 (No 336/T-1). Written informed consent in accordance with the Declaration of Helsinki was obtained from each healthy volunteer. The study group was divided into two subgroups where the individuals were intranasally administered into both nostrils of BioBlock® formulation which contained either 0.1 mg/mL or 0.2 mg/mL of the colostrum immunoglobulin preparation (n=8 in both study groups). A filter paper with a volume capacity of 15 µL was placed on the medial nasal surface using surgical forceps and it was kept on nasal mucosa for 10 minutes. Following this the BioBlock was administered to the nasal cavity. The nasal mucosal sampling was done at 4 timepoints. The samples were analyzed using a Cow IgG ELISA kit.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Trial of Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum
Actual Study Start Date : March 20, 2021
Actual Primary Completion Date : March 28, 2021
Actual Study Completion Date : June 3, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: BioBlock® concentration 0.2 mg/mL
BioBlock®: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum
Other: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum
Concentration of active substance on nasal mucosal surface in time

Active Comparator: BioBlock® concentration 0.1 mg/mL
BioBlock®: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum
Other: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum
Concentration of active substance on nasal mucosal surface in time




Primary Outcome Measures :
  1. Antibody concentration dynamics [ Time Frame: 4 hours ]
    Concentration of bovine IgG at different timepoints



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy individuals
  • Age 18-80
  • Have not been diagnosed with SARS-COV-2 infection (lack of positive PCR test)
  • Have not been vaccinated against SARS-COV-2 infection

Exclusion Criteria:

  • Pregnancy
  • Serious allergic or anaphylactic reactions to medications
  • Allergies to milk products
  • Ear-nose-throat pathologies (anatomic and diseases)
  • Immunodeficiency conditions (cancers, hematologic diseases, HIV, congenital immunodeficiency)
  • Viral hepatitis A,B and C
  • Upper airway infections
  • Autoimmune diseases (diabetes, COPD, asthma, rhinitis, RA, psoriasis)
  • Concomitant drugs - glucocorticosteroids, biologic drugs, inhalable medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04916574


Locations
Layout table for location information
Estonia
Icosagen AS
Tartu, Estonia, 61713
Sponsors and Collaborators
Icosagen Cell Factory
Tartu University Hospital
Layout table for additonal information
Responsible Party: Icosagen Cell Factory
ClinicalTrials.gov Identifier: NCT04916574    
Other Study ID Numbers: Ico-CT001
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs